Efficacy and Safety of the Fixed-dose Combination Atorvastatin/Fenofibrate vs Atorvastatin in Patients With T2D and DLP.

Laboratorios Silanes

Status and phase: Unknown; Phase 3

Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus

Treatments: Drug: Atorvastatin (Lipitor ®); Drug: Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT04882293

SIL-30301-III-20(1)

Details and patient eligibility

About

Phase IIIb, randomized, longitudinal, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia.

Full description

To assess the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia. Assessing the magnitude of change in lipid profile numbers. And describing the effect on anthropometric, biochemical and clinical indicators, as well as events and adverse reactions that may occur. In patients diagnosed with type 2 diabetes and dyslipidemia (triglycerides> 150 mg / dl, LDL (Low density lipoprotein) cholesterol> 100 mg / dl) and who require pharmacological treatment for lipid control.

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• That the subject agrees to participate in the study and gives their informed consent in writing.
• Both genres.
• Age 18 to 75 years old.
• Diagnosis of type 2 diabetes mellitus with adequate glycemic control defined by HbA1c ≤ 7.5% at the time of selection.
• Diagnosis of dyslipidemia prior to the start of the study (LDL cholesterol> 100 mg / dl and triglycerides> 150 mg / dl).
• Willing to avoid sexual contact or to use a barrier method of contraception while conducting the study.

Exclusion criteria

• The drug is contraindicated for medical reasons.
• Consumption of oral contraceptives, cyclosporine or strong cytochrome p450 (CYP) 3A4 inhibitors, protease inhibitors, erythromycin and azoles.
• Patients with Type 1 Diabetes Mellitus.
• Acute or Severe renal dysfunction (glomerular filtration <30 ml / min / 1.72 m2).
• History of chronic liver disease or ALT and / or AST ≥ 2 times the upper limit of normal, or GGT ≥3 times the upper limit of normal.
• Chronic or acute pancreatitis except for acute pancreatitis due to severe hypertriglyceridemia (defined by the presence of triglycerides> 1000 mg / dl and / or milky plasma, in the absence of other etiological factors of pancreatitis).
• Patients with active gallbladder disease (defined as acute or chronic gallbladder disorders associated with clinical signs or symptoms).
• Patient with a history or presence of myopathies.
• Pregnant or lactating women.
• Known contraindication or hypersensitivity to the use of any of the components of the investigational drug.
• The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
• At the medical discretion, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: end-stage cancer, kidney, heart, respiratory or liver or mental failure or with scheduled surgical or hospital procedures.
• Be a patient with a working relationship with the principal investigator or the research center or prisoner.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 2 patient groups

Group A: Atorvastatin / Fenofibrate in fixed dose

Experimental group

Description:

Group A: Atorvastatin / Fenofibrate in fixed dose Pharmaceutical Form: Tablets Dosage: 20 mg /160 mg Adminstration way: Oral

Treatment:

Drug: Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose

Group B: Atorvastatin (Lipitor ®)

Active Comparator group

Description:

Group B: Atorvastatin (Lipitor ®) Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration wat: Oral

Treatment:

Drug: Atorvastatin (Lipitor ®)